Aktuelle Aspekte zur Konzeption und Entwicklung pflanzlicher Gesundheitsprodukte / Teil 1
Isabell Gögge1, Prof. Matthias Melzig2 und Prof. Marion Schaefer1
Charité Universitätsmedizin Berlin1 und Institut für Pharmazie, Freie Universität Berlin2
The market for plant-based health products administered in dosage forms typical for medicinal products, is accompanied by a legal debate concerning the differentiation between drugs and food products. According to European law several product categories can be considered when a new product is to be developed and introduced into the market: herbal medicinal product, traditional herbal medicinal product, food supplement and dietary food for special medical purposes. The conception of a health product containing plant-based ingredients is a complex process. However, the decision on the most suitable product category has to be taken at an early stage of the product development. In addition, the legal status of the four categories and the economic consequence have to be considered. Therefore, there is a need for basic criteria both from the regulatory framework of the product categories as well as from the legal rules for differentiation between drugs and foods, which provide guidance for the decision-making process for the development of plant-based health products.
pharmind 2009, Nr. 10, Seite 1702